Serve as the main point of contact for external regulatory authorities and internal teams on regulatory matters.
Oversee daily QC testing for physical, chemical, and microbiological parameters for raw materials, packaging materials, in-process samples, and finished products.
Establish, review, and maintain QA documentation, including Standard Operating Procedures (SOPs), Certificate of Analysis (CoA), Batch Production Records (BPR), and product specifications.
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Serve as the main point of contact for external regulatory authorities and internal teams on regulatory matters.
Oversee daily QC testing for physical, chemical, and microbiological parameters for raw materials, packaging materials, in-process samples, and finished products.
Establish, review, and maintain QA documentation, including Standard Operating Procedures (SOPs), Certificate of Analysis (CoA), Batch Production Records (BPR), and product specifications.
...
NPRA & Regulatory Compliance: Lead and coordinate product registration, notifications, and variations with the National Pharmaceutical Regulatory Agency (NPRA / KKM). Prepare, review, and organize complete regulatory dossiers (Dossier submission, Certificate of Free Sale, ingredients validation, etc.).
Stay up to date with Malaysia food and health supplement regulations, ensuring all raw materials, formulations, and labeling meet current NPRA and KKM requirements. Serve as the main point of contact for external regulatory authorities and internal teams on regulatory matters.
Quality Assurance & Quality Control (QA/QC): Oversee daily QC testing (physical, chemical, and microbiological parameters) for raw materials, packaging materials, in-process samples, and finished products. Establish, review, and maintain QA documentation, including Standard Operating Procedures (SOPs), Certificate of Analysis (CoA), Batch Production Records (BPR), and product specifications.
...
NPRA & Regulatory Compliance: Lead and coordinate product registration, notifications, and variations with the National Pharmaceutical Regulatory Agency (NPRA / KKM). Prepare, review, and organize complete regulatory dossiers (Dossier submission, Certificate of Free Sale, ingredients validation, etc.).
Stay up to date with Malaysia food and health supplement regulations, ensuring all raw materials, formulations, and labeling meet current NPRA and KKM requirements. Serve as the main point of contact for external regulatory authorities and internal teams on regulatory matters.
Quality Assurance & Quality Control (QA/QC): Oversee daily QC testing (physical, chemical, and microbiological parameters) for raw materials, packaging materials, in-process samples, and finished products. Establish, review, and maintain QA documentation, including Standard Operating Procedures (SOPs), Certificate of Analysis (CoA), Batch Production Records (BPR), and product specifications.
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